We are currently looking for a Senior Scientist Analytical Development to join a leading biopharmaceutical company based in Oxfordshire. As the Senior Scientist - Analytical Development, you will be responsible for developing, optimizing, qualifying, and validating analytical methods to evaluate both drug substances and drug products from preclinical through late-phase clinical development.

Key Duties and Responsibilities:

Your duties as the Senior Scientist - Analytical Development will be varied; however, the key duties and responsibilities are as follows:

1. Manage the development, qualification, and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.

2. Support release and stability testing performed in-house and at contract research organizations (CROs), and direct good manufacturing practices (GMP) investigations, including deviation root cause analyses, corrective action preventative action (CAPA), and out-of-specification (OOS) issues.

3. Develop strategies for evaluating and implementing new technologies within Analytical Development.

4. Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.

Role Requirements:

To be successful in your application to this exciting role as the Senior Scientist - Analytical Development, we are looking to identify the following on your profile and past history:

1. Relevant MSc or PhD degree in a biological science (e.g. biochemistry or equivalent).

2. Proven industry experience working in a cGMP quality environment.

3. A working knowledge and practical experience with GMP testing environments, including an understanding of regulatory requirements and trends related to analytics and product development.

Key Words:

Senior Scientist / Analytical Development / Biopharmaceutical / Oxfordshire / GMP / cGMP / Quality Control / Method Validation / Drug Development / Biochemistry

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications for any applicant who fulfils the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.